Clinical Evaluation of the i-STAT TBI Test

The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).

Patients will be asked to provide a blood sample.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

About this study

The purpose of this study is to evaluate the clinical performance of the i-STAT TBI test for the proposed intended use; to assist in determining the need for a computed tomography (CT) scan in patients presenting with suspected mild traumatic brain injury (TBI) who are 18 years of age or older.

The secondary objective of this study is the collection of additional data and specimens from all study subjects that may support other purposes related to the understanding of TBI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Acute Blood Biomarker Branch Subject Inclusion Criteria:

18 years of age or older.
Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury.
Subject has a CT scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility or are transferred to the enrolling facility with a head CT scan sent from the originating facility.
As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following.

Any period of loss of consciousness
Any loss of memory for events immediately before or after the injury
Any alteration of mental state at the time of the injury
Focal neurological deficits that may or may not be transient

Acute Blood Biomarker Branch Subject Exclusion Criteria.

Previous enrollment in this study
Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
Time of injury is unknown and cannot be estimated
Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association [ASIA] score of C or worse) at the enrolling facility
Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
Prisoners or patients in custody
Patients on psychiatric hold

Treatment and study plan

Blood draw

Diagnostic Test

Venous whole blood collection within 12 hours and 12-24 hours following injury.

Outcome assessments

Other

Administered at baseline.

Primary outcomes

i-STAT TBI Test relative to standard of care Computed Tomography (CT) findings.

Time frame: Within 24 Hours of Traumatic Brain Injury (TBI)

Results of the i-STAT TBI Test (elevated/not elevated) relative to CT findings (+/-) for intra-cranial lesions for each subject.
Clinical performance measurement of the i-STAT TBI Test.

Time frame: Within 24 hours of Traumatic Brain Injury (TBI)

Clinical performance metrics included, clinical sensitivity, clinical specificity, negative predictive value (NPV), positive predictive value (PPV), adjusted negative predictive value (adj. NPV) calculated to a 6% CT positive prevalence rate, negative likelihood ratio (neg. LR) and positive likelihood ratio (pos. LR).

Sponsors and collaborators

Lead sponsor

Abbott Point of Care

Industry

Collaborators

United States Department of Defense
University of California, San Francisco

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Nov 21, 2019
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed